Ascend Laboratories recalls 110mg Dabigatran etexilate capsules (NDC 0904-7254-68) manufactured by Alkem Laboratories in India. The capsules failed impurity tests, potentially causing safety issues. Consumers should contact the manufacturer for details.
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Ascend Laboratories is recalling 110mg Dabigatran etexilate capsules that failed impurity tests. This could pose safety risks if the capsules are taken without proper quality control.
The capsules showed impurities that could affect safety during long-term storage. This means the medication might not work as intended or could cause adverse effects if taken.
Prescription drug users who purchased the specific lot (25141707) from the distributor in India. Those with medical conditions requiring blood thinners are most at risk.
Check for the NDC code 0904-7254-68 on the packaging. The lot number 25141707 was manufactured by Alkem Laboratories in Mumbai, India.
Reach out to Ascend Laboratories for specific instructions on how to handle the recalled capsules.
The recall indicates potential impurity issues, but the official notice does not specify if the product is safe to take.
Look for the NDC code 0904-7254-68 and lot number 25141707 on the packaging.
The official notice does not specify a remedy, so contact Ascend Laboratories for instructions.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0735-2026 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0735-2026 from Ascend Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
